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ISO 13485:2016 Flag

Medical devices -- Quality management systems -- Requirements for regulatory purposes. Design refreshed to recognize 2016-17 standard updates.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

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3x5' Flag fsS52F02161
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